Affimed Inc. (NASDAQ:AFMD) has announced the publication of the Phase 1b combination study of AFM13, its CD30/CD16A innate cell engager (ICE®) with KEYTRUDA in the American Society of Haematology Journal Blood.
AFM13 combination with KEYTRUDA shows 88% ORR and 46% CR
The published results show encouraging efficacy signs including a complete response of 46% and an objective response rate of 88% at the highest dose. In the KEYNOTE-087 study, KEYTRUDA as a monotherapy showed a complete response of 22.4% and an objective response rate of 69%.
The company’s chief medical officer, Dr. Andreas Harstrick said that the study demonstrated that ICE®’s combination with PD-1 checkpoint inhibitor administration is safe with manageable adverse events. Harstrick said that the CR and ORR reported in the proof-of-concept study of ADM13 combination with KEYTRUDA is encouraging. The results demonstrate that innate immunity activation could improve existing therapies.
KEYNOTE-87 study evaluated the efficacy and safety of AFM13 combined with KEYTRUDA in 30 R/R Hodgkin lymphoma patients there heavily pre-treated before. The combination’s safety profile was well-tolerated and consistent with currently known KEYTRUDA and AFM13 profiles. There were low-grade adverse events that were manageable with currently available standard-of-care therapies.
AFM13 activates innate immunity by CD161-directed tumor cell killing
Interestingly AFM13 currently presents a new approach of innate immunity activation through CD16A-targeted tumor-cell killing by macrophages and NK cells. The approach of innate immunity engagement in killing tumor cells is novel. The study supported the idea of a combination with an established therapy like an immune checkpoint inhibitor releasing brakes on adaptive immune responses. ICE® AFM13 enhances PD-1 checkpoint inhibitor thus triggering Immune System arms against tumors.
Lead publication author, Dr. Nancy Barlett said that there is a huge unmet need for Hodgkin lymphoma patients that are refractory of have relapsed on existing therapies. Unfortunately for the patient population, the current therapies don’t show durable efficacy. Interestingly KEYTRUDA and AFM13 combination showed CR of 46% and ORR of 88% in heavily pre-treated patients and the combination was well tolerated. She added that encouraging data demonstrates that there are possible treatment alternatives expected for patients having limited treatment alternatives.